Condition category
Cancer
Date applied
25/08/2010
Date assigned
06/09/2010
Last edited
06/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Schlenk

ORCID ID

Contact details

University Ulm Medical School
Department of Internal Medicine III
Ulm
89081
Germany
richard.schlenk@uniklinik-ulm.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI-PNP-_01_10 (sponsor), DJCLS R 09/22 (funder)

Study information

Scientific title

Effects of whole-body vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function and muscular strength: a randomised controlled trial in chemotherapy-related polyneuropathy

Acronym

Study hypothesis

Based on a further development of kinesthetic nursing, Viv-Arte® Training conception (VAT) includes
1. Manual therapy
2. Gymnastic exercise
3. Functional training
Whole-body vibration has proved to help persons who are bedridden or otherwise unable to exercise, maintaining muscular strength needed for activities of daily living. It is hypothised, that patients suffering from chemotherapy-related polyneuropathy could also benefit from whole-body vibration exercise, when added to VAT. Therefore, the trial at hand compares randomised groups treated with VAT versus VAT + whole-body vibration.

Ethics approval

University of Ulm (Germany) Ethics Board approved on May 25th, 2010 (ref: 27/10 UBB/bal)

Study design

Open label single centre randomised active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Polyneuropathies, secondary to haematologic neoplasms and chemotherapy

Intervention

Control group and experimental group:
15 sessions (two per week) of 60 minutes each, containing VAT manual therapy and functional training. The latter will be skipped for patients who are not reliant upon personal assistance for mobility tasks (according to MOTPA, see secondary outcome measurements). Gymnastic exercise is instructed individually during the session, but should be conducted between sessions. Patients receive a diary and a pedometer for documentation of exercise including walking.

Experimental group only:
In each session, whole-body vibration exercise is integrated after manual therapy. Using a Galileo® training platform, a side-alternating motion similar to a seesaw movement is applied. Amplitude and frequency are variable and will be individually adjusted.

Additional scientific contacts:
Michael Brach
Institute of Sport Science
University of Muenster
Germany
Email: michael.brach@uni-muenster.de

Eva-Maria Panfil
Institute of Applied Nursing Sciences
St. Gallen University of Applied Sciences
Switzerland
Email: evamaria.panfil@fhsg.ch

Jörn Rittweger
Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
United Kingdom
Email: j.rittweger@mmu.ac.uk

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Chair Rising Test (5 times standing up from a chair) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session

Secondary outcome measures

1. Bipedal jump test and balance test using a force plate (Leonardo® Mechanography) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
2. Functional mobility measured using motor tests including the Timed up and go test (TUG) and the Mobility test for patients in acute care (MOTPA) at baseline and 15th (last) exercise session
3. Quality of life, measured using the EORTC Quality of Life Core Questionnaire (QLQ-C30), Version 3.0, at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
4. Neurotoxicity, measured using the FACT/GOG Ntx (Funktional Assessment of Cancer Therapy/Gynecologie Onkcology Group - Neurotoxity) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session
5. Paresthesia, measured using the Visual Analogue Scale (VAS) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
6. Sensory function, measured at baseline and 15th (last) exercise session, using a standardized quantitative sensory testing (QST) battery:
6.1. Thermal detection threshold, using a computer controlled thermode
6.2. Tactile detection threshold, using von-Frey hairs
6.3. Mechanical pain threshold/sensitivity for pinprick and for light touch, including wind-up (series) sensitivity
6.4. Vibration detection threshold, using a tuning fork
6.5. Pressure pain threshold, using a pressure algometer
7. In order to estimate velocity of nerve conduction as well as sensory and motor evoked potentials (SNAP, MEP), additional electrophysiological measurements will be taken on the discretion of the neurologist

Overall trial start date

01/07/2010

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 70 years
2. Polyneuropathy diagnosed (MeSH D011115)
3. Ongoing or finished chemotherapy due to hematologic neoplasms (MeSH D019337)
4. Contiguity between polyneuropathy and chemotherapy supposable
5. Chair Rising Test with pathological score (> 10 s)
6. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

122

Participant exclusion criteria

1. Blood coagulation disorder
2. Infection beyond control
3. Thrombosis within 6 months before the trial
4. Severe neurological or psychiatric disorder, which might impair the validity of informed consent or the compliance with trial interventions
5. Epilepsy
6. Pregnacy

Recruitment start date

01/07/2010

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Ulm Medical School
Ulm
89081
Germany

Sponsor information

Organisation

University Ulm Medical School (Germany)

Sponsor details

Nursing Management
Albert-Einstein-Allee 29
Ulm
89081
Germany
+49 (0)731 50043055
elisabeth.kirchner@uniklinikum-ulm.de

Sponsor type

University/education

Website

http://www.uniklinik-ulm.de/struktur/zentrale-einrichtungen/pflegedienst

Funders

Funder type

Charity

Funder name

German Jose Carrera Leukaemia Foundation (Deutsche José Carrera Leukämie Stiftung e.V.) (Germany) - (DJCLS R 09/22)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NOVOTEC Medical GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Viv-Arte® Bewegungsschule (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes